News | April 29, 2009

Long-Term Cardiovascular Study Selects OpenClinica Enterprise Management Solution

April 29, 2009 - The Abuja Heart Study, a long-term cardiovascular study involving up to 10,000 patients from multiple sites across Nigeria, will employ the OpenClinica Enterprise for electronic data capture and clinical data management.

Data is not yet available to determine the magnitude and social burden of cardiovascular disease or the distribution within the population of many countries, including Nigeria, where it is expected to become a leading cause of death within the next 10 to 15 years.

In many ways analogous to the well-known Framingham Heart Study, the Abuja Heart Study will help scientists understand the role socio-cultural and hereditary factors play in a specific population in order to adopt targeted policies for prevention and control.

OpenClinica is open source, Web-based clinical trials software for electronic data capture (EDC) and clinical data management (CDM) that reportedly facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulator guidelines and is designed as a lightweight, standards-based, extensible and modular platform.

"This study has some specific requirements for its electronic data capture and data management needs," said Study Director Uchenna Onyeachom. "We require a lightweight, standards-based, and regulatory compliant system that can function well in resource constrained settings and is intuitive to remote users with minimal training. The flexible OpenClinica technology and enterprise open source approach from Akaza provide us with these benefits and give us the necessary assurance that many years from now our study will still be run with robust and well-supported software."

Collaborators on Abuja Heart Study include the Harvard Clinical Research Institute, Byrne Healthcare, Federal Ministry of Health Nigeria and Healthsystem Plus.

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